Indication¹

• ULTANE^® (sevoflurane) is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of ULTANE should be used.

Safety Considerations

ULTANE can cause malignant hyperthermia. ULTANE is contraindicated in patients with known sensitivity to any of its product ingredients, or to other halogenated agents, or in patients with known or suspected susceptibility to malignant hyperthermia. Use of ULTANE for more than 2-MAC hours at flow rates of 1 to <2 L/min may be associated with a potential for renal injury, glycosuria, and proteinuria. Fresh gas flow rates <1 L/min are not recommended. KOH containing CO₂ absorbents are not recommended for use with ULTANE. Patients may develop perioperative hyperkalemia, excessive decreases in blood pressure, respiratory depression, seizures, and postoperative hepatic dysfunction or hepatitis with or without jaundice.

Important Safety Information¹

• Sevoflurane can cause malignant hyperthermia. ULTANE should not be used in patients with known sensitivity to sevoflurane, or to other halogenated agents, or in patients with known or suspected susceptibility to malignant hyperthermia.
• Findings taken from patient and animal studies suggest that there is a potential for renal injury when ULTANE is used at low flow rates, which is presumed due to Compound A. The level of Compound A exposure at which clinical nephrotoxicity might be expected to occur has not been established. To minimize exposure to Compound A, ULTANE exposure should not exceed 2 MAC-hours at flow rates of 1 to <2 L/min. Fresh gas flow rates <1 L/min are not recommended.
• Because clinical experience in administering ULTANE to patients with renal insufficiency (creatinine >1.5 mg/dL) is limited, its safety in these patients has not been established.
• ULTANE may be associated with glycosuria and proteinuria when used for long procedures at low flow rates.
• KOH containing CO₂ absorbents are not recommended for use with ULTANE. An exothermic reaction occurs when ULTANE is exposed to CO₂ absorbents. This reaction is increased when the CO₂ absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO₂ absorbent canisters. Rare cases of extreme heat, smoke, and/or spontaneous fire in the anesthesia breathing circuit have been reported during ULTANE use in conjunction with the use of desiccated CO₂ absorbent, specifically those containing potassium hydroxide (e.g. Baralyme). Replace CO₂ absorbents routinely regardless of the state of the color indicator.
• Rare increases in serum potassium resulting in cardiac arrhythmias and death have been noted in pediatric patients during the postoperative period following the use of inhaled anesthetic agents. Contributing risk factors appear to be latent or overt neuromuscular disease, particularly Duchenne muscular dystrophy. Concomitant use of succinylcholine has been associated with most, but not all of these cases. Early, aggressive intervention to treat both hyperkalemia and resistant arrhythmias, and subsequent evaluation for latent neuromuscular disease, is recommended.
• Due to ULTANE’s insolubility in blood, hemodynamic changes may occur more rapidly than with other volatile anesthetics. Excessive decreases in blood pressure or respiratory depression may be related to depth of anesthesia and may be corrected by decreasing the inspired concentration of ULTANE.
• Seizures have been reported in association with ULTANE use, the majority of which have occurred in children and young adults, most of whom had no predisposing risk factors. Clinical judgment should be exercised when using ULTANE in patients who may be at risk for seizures.
• Drug Interactions: Benzodiazepines and opioids would be expected to decrease the MAC of ULTANE. The anesthetic requirement for ULTANE is decreased when administered in combination with nitrous oxide. ULTANE increases both the intensity and duration of neuromuscular blockade induced by nondepolarizing muscle relaxants.
• Very rare cases of mild, moderate, and severe postoperative hepatic dysfunction or hepatitis with or without jaundice have been reported from postmarketing experiences. In addition, rare postmarketing reports of hepatic failure and hepatic necrosis have been associated with the use of ULTANE. Clinical judgment should be used in patients with underlying hepatic conditions or who are under treatment with drugs known to cause hepatic dysfunction.
• Adverse events reported by ≥5% of the surgical patients receiving ULTANE during clinical trials during induction included: bradycardia, tachycardia, agitation, laryngospasm, airway obstruction, breathholding, and increased cough; while during maintenance and emergence: shivering, hypotension, bradycardia, somnolence, agitation, nausea, vomiting, and increased cough were reported.

Reference: 1. ULTANE [package insert]. North Chicago, IL: Abbott Laboratories.